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Manager, Validation

2 months ago

Hightstown, United States Empower Pharmacy Full time
Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on three core values: People, Quality and Service. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you'll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let's revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

The role of a Validation Manager at Empower is essential to maintaining the highest standards of compliance, quality, and innovation. This position is vital in overseeing the qualification and validation of our facilities, utilities, equipment, computer systems, and processes in accordance with current regulations. By supervising the generation, execution, review, and summarization of validation protocols, you will ensure that our operations align with our core values of people, service, quality, and innovation.

As a central point of contact for coordinating validation project activities, you will collaborate with quality assurance (QA), manufacturing, engineering, quality control (QC), and other stakeholders. Your expertise will be crucial in managing and tracking commissioning, qualification, and validation (CQV) and technical transfer projects using project management tools. Leading technical transfer activities between sites, you will provide technical advice on new equipment and modifications to maintain validation and qualification status.

In this role, you will execute and manage risk assessments for validation processes, ensuring compliance with regulatory standards and internal quality requirements. Your knowledge of risk analysis (RA) methodologies, such as failure mode and effects analysis (FMEA) and hazard analysis and critical control points (HACCP), will drive continuous improvement by enhancing equipment, system, and process robustness. Supporting corrective and preventive actions (CAPA), change control, deviation, risk analysis, root cause analysis, and impact assessments, you will be instrumental in optimizing manufacturing efficiency and output performance.

We invite you to apply for this exciting opportunity at Empower, where your skills will contribute to producing innovative medications that help people live healthier, happier lives. Join us in expanding access to quality, affordable medication and be part of a team dedicated to making a difference in the world.

Duties and Responsibilities

  • Oversees the qualification and validation of facilities, utilities, equipment, computer systems, and processes as required per current regulations.
  • Supervises the generation, execution, review, and summarization of facilities, equipment, systems, utilities, and process validation protocols.
  • Manages and tracks CQV and technical transfer projects using project management tools.
  • Collaborates with QA, manufacturing, engineering, QC, and other relevant stakeholders, acting as the central point of contact for coordinating validation project activities, to ensure all project requirements are completed on time and within budget.
  • Leads technical transfer activities between sites and client sites.
  • Provides technical advice on new equipment and modifications to existing equipment to ensure validation/qualification status is maintained in a state of control.
  • Leads the execution and management of risk assessments for validation processes within the organization, ensuring compliance with regulatory standards and internal quality requirements. Utilizes RA methodologies such as FMEA, HACCP, and other relevant tools.
  • Drives continuous improvement by managing projects and recommending techniques to enhance equipment/system/process robustness, improving manufacturing efficiency and output performance.
  • Supports CAPA, change control, deviation, RA, root cause analysis, impact assessments, and other quality systems.
  • Trains personnel to operate equipment, perform sampling, and execute processes.
  • Manages external contractors and vendors executing CQV activities.
  • Participates in regulatory audits.
  • Performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills
  • Advanced knowledge of current good manufacturing practice and regulatory requirements related to commissioning, qualification, and validation.
  • Advanced knowledge of cleaning, sterilization, process, and computer systems validation.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations.
  • Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
  • Excellent organization, prioritization skills, and the ability to multitask.
  • Certified quality engineer desirable.
Key Competencies
  • Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
  • Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
  • Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
  • Resourcefulness: Secures and deploys resources effectively and efficiently.
  • Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
  • Ensures Accountability: Holds self and other accountable to meet commitment.
  • Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
  • Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Experience and Qualifications
  • Bachelor of Science degree in a scientific or engineering discipline or non-specific Bachelor of Science degree and considerable validation experience.
  • Minimum of twelve (12) years validation experience in the pharmaceutical or biotechnology industries, with at least two (2) years in a managerial or supervisory role.
Employee Benefits, Health, and Wellness
  • No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
  • Onsite Health & Wellness - IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
  • Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
  • Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
  • Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
  • Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
  • Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
  • FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
  • 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
  • Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
  • Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
  • Rewards & Recognition Program: Your hard work doesn't go unnoticed - enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
  • Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
  • Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
  • Critical Illness: Protect your finances from the expenses of a serious health issue.
  • Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
  • Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
  • Legal Services: Access professional legal assistance to address concerns confidently.
  • Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
  • Pet Insurance: Care for your furry family members with our pet insurance coverage.
  • Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.